Seattle Genetics and Astellas reported positive topline results from the first cohort of patients enrolled in EV-201, a pivotal phase 2 single-arm clinical trial. The cohort is evaluating enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who have received previous treatment with both platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor. Results showed a 44% objective response rate (ORR) per blinded independent central review. The most common treatment-related adverse events included fatigue, alopecia, decreased appetite, rash and peripheral neuropathy. The EV-201 phase 2 trial continues to enroll patients in cohort 2.
The companies plan to submit a Biologics License Application (BLA) to the FDA later this year based on the results from the EV-201 trial (cohort 1). A global, randomized phase 3 clinical trial (EV-301) is ongoing and intended to support global registration as well as to serve as the confirmatory randomized trial for enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer who have been previously treated with a platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor.
About urothelial cancer
Urothelial cancer is the most common type of bladder cancer (90 percent of cases). In 2018, more than 82,000 people were diagnosed with bladder cancer in the United States. Globally, approximately 549,000 people were diagnosed with bladder cancer last year, and there were approximately 200,000 deaths worldwide. Approximately 80 percent of people do not respond to PD-1 or PD-L1 inhibitors after a platinum-containing therapy has failed as an initial treatment for advanced disease. There are currently no approved therapies for metastatic urothelial cancer once it has progressed after chemotherapy and a PD-1 or PD-L1 inhibitor.
About Enfortumab vedotin
Enfortumab vedotin is an investigational antibody-drug conjugate (ADC) that targets Nectin-4, a therapeutic target that is highly expressed in multiple solid tumors including urothelial cancers.
Enfortumab vedotin was granted Breakthrough Therapy designation by the U.S. FDA for patients with locally advanced or metastatic urothelial cancer whose disease has progressed during or following treatment with a PD-1 or PD-L1 inhibitor.
Seattle Genetics and Astellas are co-developing enfortumab vedotin under a collaboration that was entered into in 2007 and expanded in 2009. Under the collaboration, the companies are sharing costs and profits on a 50:50 basis worldwide.